Practices
Industries

Key Changes to the Law on Circulation of Medicines

14 March 2024
On January 30, 2024, the President of Russia signed Federal Law No. 1-FZ, which introduced substantial amendments to Federal Law No. 61-FZ dated April 12, 2010 ("Law on Circulation of Medicines").

The legislative novelties are primarily aimed at harmonizing national regulation and rules established in the EAEU unified market.

Decisions on Issuing Compulsory Licenses Will Now be Made by a Subcommittee Under the Russian Government

26 February 2024

On 15 February 2024, the President of the Russian Federation signed Decree No. 122 “On Improving the Procedure for Decision-Making on the Use of Inventions, Utility Models and Industrial Designs to Ensure the Economic Security of the Russian Federation” (“Decree”), which requires the Russian Government to form a Sub-commission on the use of inventions, utility models and industrial designs (“Sub-Commission”). The Sub-Commission will be formed under the Government Commission on Economic Development and Integration.

Legal Сosts Incurred in the Rospatent Dispute Can Be Reimbursed from The Losing Party

29 January 2024

The Federation Council has approved the draft law No. 390361-8 “On Amending Article 1248 of Part Four of the Russian Civil Code” (the “Draft law”). The Draft law will shortly be signed by the President and will enter into force 10 days after its publication.

According to the Draft law, article 1248(2) of the Russian Civil Code will be amended with a provision on the possibility to reimburse the costs borne before Rospatent from the losing party.

Transactions Involving Intellectual Property May Require Prior Permission of the Government Commission

15 December 2023

The Russian Ministry of Industry and Trade has drafted amendments to Presidential decree No. 81 of March 1, 2022 (the "Decree"), which would extend the special procedure for transactions established by the Decree to transactions involving intellectual property. The draft is currently at the stage of anti-corruption expertise.

In accordance with the current version of the Decree, certain types of transactions with persons from "unfriendly" countries may be carried out only on the basis of permits issued by the Government Commission for Monitoring the Implementation of Foreign Investments in the Russian Federation (the "Government Commission").

The Court Ordered for the First Time a Compulsory License for a Series of Pharmaceutical Patents on the Grounds of Lack of Use in Russia

05 October 2023

By its Ruling of 25.09.2023 in case No. A40-185112/2022, the Ninth Commercial Court of Appeal ordered the pharmaceutical company Vertex, the right holder of a series of patents for the drug Trikafta (INN: Ivacaftor+Tezacaftor+Elexacaftor, Ivacaftor), to grant a simple (non-exclusive) license to the Russian pharmaceutical company MIK under Article 1362(1) of the Russian Civil Code (insufficient use of patents).